Assess Incidence of Deep Vein Thrombosis(DVT)Following Administration of Recombinant Human Antithrombin (rhAT) to Hereditary Antithrombin(AT) Deficient Patients in High Risk Situations. (rhAT)
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|ClinicalTrials.gov Identifier: NCT00056550|
Recruitment Status : Completed
First Posted : March 18, 2003
Results First Posted : October 16, 2012
Last Update Posted : October 16, 2012
|Condition or disease||Intervention/treatment||Phase|
|Antithrombin Deficiency, Congenital||Biological: Recombinant Human Antithrombin (rhAT)||Phase 3|
- Assess the safety of recombinant antithrombin (rhAT) in hereditary antithrombin (AT) deficient patients.
- Assess the incidence of acute deep venous thrombosis(DVT) alone in patients with hereditary antithrombin (AT) deficiency in situations usually associated with a high risk for thromboembolic events after increasing and targeting functional AT activity at >80% and < 120% of normal by prophylactic IV administration of rhAT.
- Clinically assess and determine the relevance of thromboembolic events other than acute DVT to rhAT administration.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study to Assess the Incidence of Deep Vein Thrombosis (DVT) Following Prophylactic Intravenous Administration of Recombinant Human Antithrombin(rhAT) to Hereditary Antithrombin (AT) Deficient Patients in High Risk Situations.|
|Study Start Date :||December 2002|
|Actual Primary Completion Date :||February 2004|
|Actual Study Completion Date :||February 2004|
U.S. FDA Resources
Experimental: Recombinant Human Antithrombin (rhAT) infusion
Loading and continuous infusion dose of rhAT to target and maintain an AT activity level > 80% and < 120% of normal.
Biological: Recombinant Human Antithrombin (rhAT)
Biological/Vaccine: Recombinant human antithrombin(rhAT) Phase III clinical trial.
Other Name: ATryn
- Incidence of Thromboembolic Events Acute Deep Venous Thrombosis (DVT) and/or Thromboembolic Events Other Than Acute Deep Vein Thrombosis (DVT). [ Time Frame: Baseline, last day of dosing and day 7 (+ or - 1 day) ]Observation for clinical signs and symptoms of thromboembolic events are evaluated for acute deep vein thrombosis (DVT) using duplex ultrasonography and/or other imaging tests to confirm clinical signs/symptoms. Duplex ultrasonography was performed at baseline, last day of dosing and day 7 (+ or -1 day).
- Local Assessment of Thromboembolism by Physical Examination. [ Time Frame: 30 days after last dose ]The investigators evaluated patients for any clinical signs of thromboembolism by physical examination.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00056550
|United States, Georgia|
|Marietta, Georgia, United States|
|United States, South Carolina|
|Charleston, South Carolina, United States|
|Bristol, United Kingdom|
|Manchester, United Kingdom|
|Principal Investigator:||Cambell Tait, MD||Royal Infirmary Glaskow|